# K252698: NightGuard Aire Max

- Pathway: 510(k) (Traditional)
- Applicant: Nightguard Express, LLC
- Decided: Nov 3, 2025 after 68 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K882303 (1989). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232735: EMA 3D, Ema Sleep Incorporated (2024) Summary page 5.

## Indications for use
The NightGuard Aire Max is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Source page: https://510kreport.com/device/K252698
Methodology: https://510kreport.com/methodology